High FDA (Devices)·Z-0832-2022·Announced 2022-04-06

Ambulatory infusion pumps recalled due to erroneous software installation

InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: No illnesses or injuries reported; however, per FDA severity criteria, this Class II recall of a high-risk device (infusion pump) with software error constitutes a risk-of-harm situation classified as High (score 3).

Plain-English summary

InfuTronix LLC is recalling Nimbus PainPro Ambulatory Infusion Pumps (Model IT1072), sold as kits IT1075-DUKE-HSP, IT1076-DUKE-HSP, and IT1077-DUKE-HSP. An unreleased Version 4 Protocol Library was installed on these devices in error. These devices may impact patient safety if used on patients.

The recall affects 74 units distributed nationwide in North Carolina and Ohio. Affected devices are identified by Lot number 2009231440 and specific serial numbers ranging from 807483 to 807658. The FDA has classified this recall as Class II.

For questions or to report issues with this device, contact the FDA or InfuTronix LLC directly.

The recalled product

Product: Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Manufacturer: InfuTronix LLC
Category: Medical Device — Infusion Pump
Hazard: software-error
medication-delivery-error
Affected units: 74

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

(UDI): (01)00817170020086
Lot: 2009231440
Serial Numbers: 807483
807484
807485
807486
807487
807489
807490
807491
807492
807493
807494
807495
807496
807497
807498
807499
807500
807502

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · InfuTronix LLC

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